CFR Subpart A

CFR Subpart A
in effect

21 C.F.R. § 19.1 Scope.

This part governs the standards of conduct for, and establishes regulations to prevent conflicts of interest by, all Food and Drug Administration employees.

21 C.F.R. § 19.5 Reference to Department regulations.

(a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Administration employees, except that such regulations shall be applicable to special government employees, i.e., consultants to the Food and Drug Administration, only to the extent stated in subpart L of 45 CFR part 73. (b) The provisions of 45 CFR part 73a supplement the Department standards of conduct and apply only to Food and Drug Administration employees except special government employees.

21 C.F.R. § 19.6 Code of ethics for government service.

The following code of ethics, adopted by Congress on July 11, 1958, shall apply to all Food and Drug Administration employees: Code of Ethics for Government Service Any person in Government service should: 1. Put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department. 2. Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion. 3. Give a full day's labor for a full day's pay; giving to the performance of his duties his earnest effort and best thought. 4. Seek to find and employ more efficient and economical ways of getting tasks accomplished. 5. Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept, for himself or his family, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his governmental duties. 6. Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty. 7. Engage in no business with the Government, either directly or indirectly, which is inconsistent with the conscientious performance of his governmental duties. 8. Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit. 9. Expose corruption wherever discovered. 10. Uphold these principles, ever conscious that public office is a public trust.

21 C.F.R. § 19.10 Food and Drug Administration Conflict of Interest Review Board.

(a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall review and make recommendations to the Commissioner on all specific or policy matters relating to conflicts of interest arising within the Food and Drug Administration that are forwarded to it by: (1) The Associate Commissioner for Management and Operations or (2) anyone who is the subject of an adverse determination by the Associate Commissioner for Management and Operations on any matter arising under the conflict of interest laws, except a determination of an apparent violation of law. The Director, Division of Ethics and Program Integrity, Office of Management and Operations, shall serve as executive secretary of the Review Board. (b) It shall be the responsibility of every Food and Drug Administration employee with whom any specific or policy issue relating to conflicts of interest is raised, or who otherwise wishes to have any such matter resolved, to forward the matter to the Associate Commissioner for Management and Operations for resolution, except that reporting of apparent violations of law are governed by § 19.21. (c) All general policy relating to conflicts of interest shall be established in guidance documents pursuant to the provisions of § 10.90(b) of this chapter and whenever feasible shall be incorporated in regulations in this subpart. (d) All decisions relating to specific individuals shall be placed in a public file established for this purpose by the Division of Freedom of Information, e.g., a determination that a consultant may serve on an advisory committee with specific limitations or with public disclosure of stock holdings, except that such determination shall be written in a way that does not identify the individual in the following situations: (1) A determination that an employee must dispose of prohibited financial interests or refrain from incompatible outside activities in accordance with established Department or agency regulations. (2) A determination that a proposed consultant is not eligible for employment by the agency. (3) A determination that public disclosure of any information would constitute an unwarranted invasion of personal privacy in violation of § 20.63 of this chapter.

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